Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.

NCT02206308 | Completed Phase 1

• 1 other identifier: SCT400NHLI
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma

Conditions

B-cell Non Hodgkin's Lymphoma

Keywords

Chimeric anti-CD20 monoclonal antibody(SCT400); escalating doses; safety; pharmacokinetics and pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Number of participants with infusion-related reaction and with drug-related adverse events.

  up to 27 weeks

Secondary Outcomes (1)

• Area Under the plasma concentration versus time curve (AUC) of SCT400

  prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose

Other Outcomes (1)

• Time to disease progression

  up to 27 weeks

Study Arms (1)

single arm

EXPERIMENTAL

Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;

Biological: Chimeric anti-CD20 monoclonal antibody

Interventions

Chimeric anti-CD20 monoclonal antibody BIOLOGICAL

Also known as: SCT400

single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged from 18 to 75 years
• having histologically confirmed NHL expressing CD20 antigen
• having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months
• signed an informed consent form which was approved by the institutional review board of the respective medical center

You may not qualify if:

• single measurable lesion ≥7 cm in diameter
• with serious hematologic dysfunction (white blood cell count of \<3.0×103/μL; absolute neutrophil count of \<1.5×103/ μL; platelet count of \< 75×103/μL; hemoglobin level of \< 8.0 g/dL; serum immunoglobulin G(IgG) level of \<600 mg/dL);, hepatic dysfunction (total bilirubin level of \> 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of \> 1.5×ULN )
• having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
• had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
• had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry
• with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
• having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus
• with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
• with a history of allergic reaction or protein product allergy including murine proteins
• pregnant or lactating or not accepted birth control methods including male patients

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuan kai Shi, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 1, 2014
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 1, 2014

Record last verified: 2013-12